CONSHOHOCKEN, PA — Tiger BioSciences reported interim results from a randomized controlled clinical trial showing that patients with non-healing diabetic foot ulcers treated with its caregraFT™ placental membrane allograft alongside standard care achieved higher wound-closure rates than patients receiving standard care alone.
The findings, released through ClinicalTrials.gov, come as healthcare providers and payers continue to evaluate advanced wound-care products that could reduce complications associated with diabetic foot ulcers, a condition that contributes to significant healthcare costs and amputation risk nationwide.
According to the interim analysis of the ongoing TIGERCAMP trial, 46% of patients receiving caregraFT™ plus standard of care achieved complete wound closure, compared with 28% of patients treated with standard care alone.
Patients in the caregraFT™ treatment arm also recorded a 61% average reduction in wound area, versus 39% among patients receiving standard care alone.
Tiger BioSciences said an interim Bayesian analysis indicated a 96% probability that caregraFT™ provided a wound-healing benefit when added to standard care. The company reported that patients receiving the product were approximately 1.8 times more likely to achieve wound closure than those receiving standard care alone.
The multicenter TIGERCAMP study is evaluating caregraFT™ as an adjunct treatment for non-healing diabetic foot ulcers. Standard care for such wounds typically includes debridement, moisture-retentive dressings, offloading, and compression therapies.
The company reported no product-related adverse events or serious adverse events in the caregraFT™ treatment group during the interim phase of the study.
“The interim TIGERCAMP data are clear: caregraFT™ plus standard of care outperformed standard of care alone across the wound-healing measures evaluated,” Garrett Grinsfelder, president of Tiger Wound Care, said in a statement.
Tiger BioSciences said the ongoing Phase IV study is being conducted at multiple clinical sites across the United States. Primary endpoints include complete wound closure at 12 weeks, while secondary measures include wound-area reduction, time to closure, pain reduction, adverse events, and patient quality-of-life outcomes.
The company said the results are scheduled for publication in the Journal of Chronic Wound Care Management and Research. Additional study information is available through ClinicalTrials.gov under identifier NCT06826339.
As an interim analysis sponsored by the product’s manufacturer, the findings remain preliminary pending completion of the trial and peer-reviewed publication of the full study results.
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